Edwards Lifesciences LLC · Transcatheter Aortic Valve (TAVR) · First cleared May 2017
Total Reports
1,434
Reports (30d)
37
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Aortic Death Events Post-ImplantEmerging
events, data, sapien ultra, thv, death
11
reports
Serious Injury Cardiac Perforation EventsEmerging
events, injury, data, sapien ultra, thv
11
reports
Valve-in-Valve Procedure for Stenosis
ultra, clinical specialist, valve valve, field, field clinical
15
reports
Valve Stenosis 9 Years Post-Implant
clinical specialist, valve valve, approximately years, field, field clinical
13
reports
Valve Explantation 4 Years Post-Implant
valve aortic, aortic position, registry, months, ultra
9
reports
Valve Explantation 3 Years Post-TAVR
registry, transfemoral, approximately years, procedure sapien, tavr procedure
4
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Evidence
One-Year Outcomes of Mitral Valve-in-Valve Using the SAPIEN 3 Transcatheter Heart Valve
Brian Whisenant, et al. · JAMA Cardiology · 2020
Citations indexed from PubMed.
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Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 1 active signal detected right now.
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